The European Patent Office’s recent decision to partly uphold Myriad Genetics’ BRCA1 patent may create uncertainty about when laboratories conducting BRCA testing in Europe infringe the IP.
An EPO appeals board last week ended a seven-year tussle between Myriad and a number of European research groups in deciding to maintain in an amended form Myriad’s patent, EP 699754, covering a “method for diagnosing a predisposition for breast and ovarian cancer.”
Specifically, the EPO’s decision amends the patent to cover frame-shift mutations, but not missense mutations, in the BRCA1 gene. The amended patent, which cannot be further contested at the European level, does not “contain claims directed to the BRCA1 gene itself or to mutated forms thereof,” the EPO said in a statement.
Myriad was granted the EP 699754 patent in May 2001 to protect methods for using the BRCA1 and BRCA2 genes for diagnosing predisposition to breast and ovarian cancer. Later that year, a number of parties, including several French research institutes and various national centers for human genetics, filed an opposition to the patent. That opposition led the Opposition Division of the EPO to revoke the patent.
Myriad appealed the decision, requesting that the patent be maintained in a form that restricts the original patent claims. Seven years later, the board of appeal has decided to maintain the patent covering frame-shift mutations, which account for approximately 60 percent of pathogenic mutations in the BRCA1 gene.
However, now with only part of the gene’s pathogenic mutations protected by the patent, Myriad’s ability to protect its IP might be tricky, and labs that wish to continue doing BRCA gene testing could find it difficult to ascertain when they are infringing Myriad’s patents.
“It’s quite unclear … how a patent owner can enforce a patent that only partially covers a diagnostic method,” Gert Matthijs, head of the molecular diagnostic laboratory at the University of Leuven Hospital in Belgium, told Pharmacogenomics Reporter this week.
Matthijs is a member of the European Society of Human Genetics, a group that earlier this year recommended the EPO limit granting broad patents, prohibit patents for disease genes, promote new models for licensing to advance research, and work with other national governments to align gene patenting systems [see PGx Reporter 04-30-2008].
“It’s quite unclear … how a patent owner can enforce a patent that only partially covers a diagnostic method.”
According to Matthijs, patent infringement with regard to Myriad’s test might depend on the outcome of the test following the EPO’s final decision in the matter. “That outcome will be negative in a majority of the cases, since only about 10 percent of the patients with a high risk effectively have a BRCA1 mutation, and only 60 percent of these are frame-shift mutations,” he said.
In addition, the validity of Myriad’s patents is contingent on the company paying fees to national governments to maintain them.
“In those countries where this has been the case — mainly the larger [European] countries — the patent owners may choose to keep their monopoly and thus try to stop the laboratories from offering the test, or [they] may offer licenses and thus get royalties,” Matthijs said.
But even with the amended BRCA1 patent it will be “unclear whether one is already infringing by just doing the test,” he added.
In the European countries where Myriad has not maintained its patents, laboratories can perform the BRCA1 test without Myriad and the test will remain available. Ultimately, though, the EPO decision was a total victory neither for Myriad nor objectors to gene patenting.
“The decision shows that the EPO still considers genetic tests, and the identification of a link between a disease and a mutation or a set of mutations, to be patentable,” Matthijs said.
In addition, the EPO’s decision may give laboratories in Europe a little more room to negotiate licensing deals with Myriad than if the board had decided to uphold all of the patent’s claims.
“The patent owners will never have a full monopoly on the test, and hence, this may create a basis for negotiations,” Matthijs said, adding that the ruling “will probably make patent owners think twice about their licensing policy.”
A large part of the controversy surrounding Myriad’s BRCA patents concerns not just the legitimacy of the patents themselves, but also critics’ claims that Myriad charges high licensing fees, which discourage laboratories from carrying out diagnostic testing in countries where the patent is in force.
William Hockett, executive VP of corporate communications at Myriad, told Pharmacogenomics Reporter this week that although its BRACAnalysis test is “a very important contributor” to the company’s revenue, “sales from Europe are not an important contributor to our total revenue at this point.”
The EPO’s decision will allow the company “further basis to invest in commercializing our molecular diagnostic product for breast and ovarian cancer in Europe,” Hockett said.
“Research activities with the patented technologies are not limited in any way by Myriad, and are in fact encouraged through subsidized costs for testing from the company to researchers,” he added.